European Union to suspend ranitidine medicines

Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended the suspension of all medicines containing ranitidine in the European Union.

The European Medicines Agency (EMA) said the suspension was a “precaution” due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA), which is a probable human carcinogen.

The suspension follows a safety review initiated on 12 September 2019 at the request of the European Commission under Article 31 of Directive 2001/83/EC (click here to read the News story).

Follows action in the US

The move also comes just one month after the US Food and Drug Administration (FDA) asked manufacturers to withdraw all prescription and OTC medicines containing ranitidine from the market immediately (click here to read the News story).

The EMA said the available safety data did not show that ranitidine increased the risk of cancer, and any possible risk was likely to be very low.

However, the regulatory agency pointed out that NDMA had been found in several ranitidine medicines “above levels considered acceptable, and there are unresolved questions about the source of the impurities”.

The EMA said there was “some evidence that NDMA may form from the degradation of ranitidine itself with increasing levels seen over its shelf life”.

Furthermore, the EMA said it was “not clear whether NDMA can also be formed from ranitidine inside the body”. “Some studies suggest that it can while others do not,” commented the EMA.

Many ranitidine medicines have not been available in the European Union for several months, partly because some national authorities recalled them as a precaution while the EMA review was ongoing.

Conditions for lifting the suspension

The EMA noted that it had recommended conditions for lifting the suspension of ranitidine medicines, including requirements for companies to provide more data.

The CHMP’s recommendation has been forwarded to the European Commission, which will issue a final legally-binding decision applicable in all member states of the European Union.